Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 1:32 PM
Study NCT ID:
NCT00217659
Status:
WITHDRAWN
Last Update Posted:
2013-01-03
First Post:
2005-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S0511, Goserelin and Anastrozole in Treating Men With Recurrent or Metastatic Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
Study Overview
Official Title:
A Phase II Study of Goserelin Plus Anastrozole for the Treatment of Male Patients With Hormone-Receptor Positive Metastatic or Recurrent Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin and anastrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving goserelin together with anastrozole may be an effective treatment for male breast cancer.
PURPOSE: This phase II trial is studying how well giving goserelin together with anastrozole works in treating men with recurrent or metastatic breast cancer.
PURPOSE: This phase II trial is studying how well giving goserelin together with anastrozole works in treating men with recurrent or metastatic breast cancer.
Detailed Description:
OBJECTIVES:
* Determine the progression-free survival (PFS) of men with estrogen receptor- or progesterone receptor-positive recurrent or metastatic breast cancer treated with goserelin and anastrozole.
* Determine the overall survival of patients treated with this regimen.
* Determine the overall objective tumor response rate (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
* Correlate prostate specific antigen (PSA), testosterone, estradiol, estrone, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS and response in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive goserelin subcutaneously on day 1 and oral anastrozole on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at approximately 4-6 weeks and then every 3-6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within 48 months.
* Determine the progression-free survival (PFS) of men with estrogen receptor- or progesterone receptor-positive recurrent or metastatic breast cancer treated with goserelin and anastrozole.
* Determine the overall survival of patients treated with this regimen.
* Determine the overall objective tumor response rate (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
* Correlate prostate specific antigen (PSA), testosterone, estradiol, estrone, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS and response in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive goserelin subcutaneously on day 1 and oral anastrozole on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at approximately 4-6 weeks and then every 3-6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within 48 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| S0511 | OTHER | SWOG | View | |
| U10CA032102 | NIH | None | https://reporter.nih.gov/quic… | View |